ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY
FDA premarket approval P090024/S001 · decided 2016-10-18
Approval details
- PMA number
- P090024
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-05-05
- Decision date
- 2016-10-18
- Days to decision
- 532 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the migration of the ADVIA Centaur® HBeAg Assay (ADVIA Centaur® HBeAg Assay and ADVIA Centaur® HBeAg Quality Control Material) to the ADVIA Centaur® XPT system.
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